MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE REPOSITIONABLE CLIP; SINGLE USE REPOSITIONAL CLIP

Model Number HX-202UR

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2021

Event Type  malfunction  

Manufacturer Narrative

The suspect device was returned to olympus for evaluation.Upon inspection, the clip was attached to the device when it arrived.During testing, the clip opened and closed when the slider was moved.When the slider was pulled and then pushed out, the clip was not released.The limiter in the control section of the clipping device was broken off.Since breakage of the limiter located in the operating portion was confirmed, the sound described as reported ¿hear the characteristic sound snap¿ was possibly the sound when the limiter broke.The reported detachment failure was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the complaint investigation, a definitive root cause could not be determined at this time.The instruction manual states the following: 1.When pulling the slider, the operation wire, the hook and the clip arms are linked together, and they are pulled together in the proximal direction.This motion closes the clip arms.2.When the slider is further pulled after closing the clip arms, the protrusions of the clip arms will move to the outside of the clip pipe.Once it happens, the small protrusions of the clip arms will be fix to the edge of the clip pipe.As a result, the clip cannot be opened or closed.3.When the slider is further pulled after the clip does not open or close, the limiter located in the slider breaks with the noise of snapping.(the user recognizes that clipping was completed by hearing the sound.) 4.After the limiter breaks, the joint between the hook and the clip arms will be unhooked by moving the slider forward.As a result, the clip will be released from the product.

Event Description

The customer reported that a new single use repositionable clip was removed from the packaging for testing purposes only.The clip opened and closed correctly but upon releasing the clip, the ¿characteristic sound snap¿ was heard, but the clip would not detach from the applicator.There was no report of patient involvement or user harm due to the event.

Manufacturer Narrative

This report is being supplemented to provide a correction to g3 of the initial medwatch.The aware date should be 02-nov-2021.Olympus will continue to monitor field performance for this device.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.

• Brand Name: SINGLE USE REPOSITIONABLE CLIP
• Type of Device: SINGLE USE REPOSITIONAL CLIP
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13934641
• MDR Text Key: 297951529
• Report Number: 8010047-2022-05177
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 04953170345180
• UDI-Public: 04953170345180
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K123601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-202UR
• Device Lot Number: 0ZK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1